The new legislation, in particular the General Regulation on Personal Data Protection (GDPR), constitutes relatively demanding criteria on healthcare. However, the institute of medical secrets, which is an ancient medical practice and is part of various legal and professional regulations, contains many elements of today's protection of personal data and is not new among the professional medical public. Under the GDPR, however, there are steps that can be labelled as at least controversial. Such disputable measures have recently been to introduce electronic queue management systems, as we know from post offices. They are not a necessary measure for the protection of personal data in the waiting rooms of ambulances, they are not required by law, even with regard to GDPR and from the point of view of medical ethics are even at least problematic. If GDPR is applied in a similar way, it does not really benefit from the protection of personal data, and a useful tool like GDPR will be undoubtedly discredited. Keywords: electronic queue management systems, GDPR, medical ethics, personal data protection, patient.
- MeSH
- Confidentiality * MeSH
- Ethics, Medical * MeSH
- Humans MeSH
- Delivery of Health Care MeSH
- Computer Security * MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
Having the means to share research data openly is essential to modern science. For human research, a key aspect in this endeavor is obtaining consent from participants, not just to take part in a study, which is a basic ethical principle, but also to share their data with the scientific community. To ensure that the participants' privacy is respected, national and/or supranational regulations and laws are in place. It is, however, not always clear to researchers what the implications of those are, nor how to comply with them. The Open Brain Consent (https://open-brain-consent.readthedocs.io) is an international initiative that aims to provide researchers in the brain imaging community with information about data sharing options and tools. We present here a short history of this project and its latest developments, and share pointers to consent forms, including a template consent form that is compliant with the EU general data protection regulation. We also share pointers to an associated data user agreement that is not only useful in the EU context, but also for any researchers dealing with personal (clinical) data elsewhere.
- Keywords
- brain imaging, general data protection regulation, informed consent,
- MeSH
- Informed Consent * ethics MeSH
- Humans MeSH
- Brain diagnostic imaging MeSH
- Neuroimaging * ethics MeSH
- Information Dissemination * ethics MeSH
- Research Subjects * MeSH
- Check Tag
- Humans MeSH
- Publication type
- Research Support, Non-U.S. Gov't MeSH
- Research Support, N.I.H., Extramural MeSH
- Research Support, U.S. Gov't, Non-P.H.S. MeSH
- Editorial MeSH
The European Union (EU) General Data Protection Regulation (GDPR) imposes legal responsibilities concerning the collection and processing of personal information from individuals who live in the EU. It has particular implications for the remote monitoring of cardiac implantable electronic devices (CIEDs). This report from a joint Task Force of the European Heart Rhythm Association and the Regulatory Affairs Committee of the European Society of Cardiology (ESC) recommends a common legal interpretation of the GDPR. Manufacturers and hospitals should be designated as joint controllers of the data collected by remote monitoring (depending upon the system architecture) and they should have a mutual contract in place that defines their respective roles; a generic template is proposed. Alternatively, they may be two independent controllers. Self-employed cardiologists also are data controllers. Third-party providers of monitoring platforms may act as data processors. Manufacturers should always collect and process the minimum amount of identifiable data necessary, and wherever feasible have access only to pseudonymized data. Cybersecurity vulnerabilities have been reported concerning the security of transmission of data between a patient's device and the transceiver, so manufacturers should use secure communication protocols. Patients need to be informed how their remotely monitored data will be handled and used, and their informed consent should be sought before their device is implanted. Review of consent forms in current use revealed great variability in length and content, and sometimes very technical language; therefore, a standard information sheet and generic consent form are proposed. Cardiologists who care for patients with CIEDs that are remotely monitored should be aware of these issues.
- Keywords
- Cardiac implantable electronic device, Cybersecurity, Data controller, Data processor, EHRA, ESC Regulatory Affairs Committee, General Data Protection Regulation, Informed consent, Informed consent form, Joint data controller, Remote monitoring,
- MeSH
- Electronics MeSH
- Cardiology * MeSH
- Humans MeSH
- Monitoring, Physiologic MeSH
- Advisory Committees MeSH
- Computer Security MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
Health systems advance towards personalized, preventive, predictive, participative precision (5P) medicine, considering the individual's health status, contexts and conditions. This results in fully distributed, highly dynamic, highly complex business systems and processes with multiple, comprehensively cooperating actors from different specialty and policy domains, using their specific methodologies, terminologies, ontologies, knowledge and skills. Rules and regulations governing the business process as well as the organizational, legal and individual conditions, thereby controlling the behavior of the system, are called policies. Trust and confidence needed for running such system are strongly impacted by security and privacy concerns controlled by corresponding policies. The most comprehensive policy dealing with security and privacy requirements and principles in any business collecting, processing and sharing personal identifiable information (PII) is the recently implemented European General Data Protection Regulation (GDPR). This paper investigates how GDPR supports healthcare transformation and how this can be implemented based on international standards and specifications.
- Keywords
- European data protection, governing, privacy,
- MeSH
- Medicine * MeSH
- Personally Identifiable Information MeSH
- Delivery of Health Care * MeSH
- Privacy MeSH
- Computer Security * MeSH
- Publication type
- Journal Article MeSH
Most countries have acknowledged the importance of assessing and quantifying their population's internal exposure from chemicals in air, water, soil, food and other consumer products due to the potential health and economic impact. Human biomonitoring (HBM) is a valuable tool which can be used to quantify such exposures and effects. Results from HBM studies can also contribute to improving public health by providing evidence of individuals' internal chemical exposure as well as data to understand the burden of disease and associated costs thereby stimulating the development and implementation of evidence-based policy. To have a holistic view on HBM data utilisation, a multi-case research approach was used to explore the use of HBM data to support national chemical regulations, protect public health and raise awareness among countries participating in the HBM4EU project. The Human Biomonitoring for Europe (HBM4EU) Initiative (https://www.hbm4eu.eu/) is a collaborative effort involving 30 countries, the European Environment Agency (EEA) and the European Commission (contracting authority) to harmonise procedures across Europe and advance research into the understanding of the health impacts of environmental chemical exposure. One of the aims of the project was to use HBM data to support evidence based chemical policy and make this information timely and directly available for policy makers and all partners. The main data source for this article was the narratives collected from 27 countries within the HBM4EU project. The countries (self-selection) were grouped into 3 categories in terms of HBM data usage either for public awareness, policy support or for the establishment HBM programme. Narratives were analysed/summarised using guidelines and templates that focused on ministries involved in or advocating for HBM; steps required to engage policy makers; barriers, drivers and opportunities in developing a HBM programme. The narratives reported the use of HBM data either for raising awareness or addressing environmental/public health issues and policy development. The ministries of Health and Environment were reported to be the most prominent entities advocating for HBM, the involvement of several authorities/institutions in the national hubs was also cited to create an avenue to interact, discuss and gain the attention of policy makers. Participating in European projects and the general population interest in HBM studies were seen as drivers and opportunities in developing HBM programmes. A key barrier that was cited by countries for establishing and sustaining national HBM programmes was funding which is mainly due to the high costs associated with the collection and chemical analysis of human samples. Although challenges and barriers still exist, most countries within Europe were already conversant with the benefits and opportunities of HBM. This article offers important insights into factors associated with the utilisation of HBM data for policy support and public awareness.
- Keywords
- HBM4EU and HBM programme, Human biomonitoring (HBM) data, National hubs (NHs),
- MeSH
- Biological Monitoring * MeSH
- Humans MeSH
- Environmental Monitoring * methods MeSH
- Public Health MeSH
- Environmental Exposure analysis MeSH
- Policy Making MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Review MeSH
The International Maritime Organization has set a goal to achieve a 50% reduction of total annual greenhouse gas emission related to the international shipping by 2050 compared to the 2008 baseline emissions. Malaysia government has taken an initiative to investigate the assessment (cost-effectiveness) of this International Maritime Organization's short-term measure on Malaysian-registered domestic ships although this measure is only for international merchant ship. To achieve this, this paper collected the ship's data from the shipowners from 25 sample ships. Engine power limitation is the most cost-effective option, but low power limits can lead to substantially increased sailing times. Based on cost-efficiency analysis, it creates for the purpose of compliance with the operational carbon intensity indicator. It found that even if it is possible to bring an asset back into service, it may not be possible to do so in a manner that generates a profit or complies with applicable regulations. In these situations, it may be more prudent to scrap the asset rather than run the risk of having it become a stranded asset. This is especially true for older tankers. Alternatives with lengthy payback periods are not desirable for the domestic tanker fleet that is already in operation.
- Keywords
- Cost-effectiveness, Decarbonization, Malaysian-registered domestic ships, Shipping,
- MeSH
- Ships * MeSH
- Greenhouse Gases * MeSH
- Conservation of Natural Resources MeSH
- Conservation of Energy Resources MeSH
- Publication type
- Journal Article MeSH
- Names of Substances
- Greenhouse Gases * MeSH
The production of the pineal hormone melatonin is synchronized with day-night cycle via multisynaptic pathway including suprachiasmatic nucleus linking several physiological functions to diurnal cycle. The recent data indicate that impaired melatonin production is involved in several cardiovascular pathologies including hypertension and ischemic heart disease. However, the mechanisms of melatonin effect on cardiovascular system are still not completely understood. The activation of melatonin receptors on endothelial and vascular smooth muscle cells and antioxidant properties of melatonin could be responsible for the melatonin effects on vascular tone. However, the data from in vitro studies are controversial making the explanation of the melatonin effect on blood pressure in vivo difficult. In vivo, melatonin also attenuates sympathetic tone by direct activation of melatonin receptors, scavenging free radicals or increasing NO availability in the central nervous system. The central and peripheral antiadrenergic action of chronic melatonin treatment might eliminate the mechanisms counter-regulating decreased blood pressure, providing thus additional cardioprotective mechanism. The extraordinary antioxidant activity and antilipidemic effects of melatonin may enhance the modulation of blood pressure by melatonin and probably play the most important role in the amelioration of target organ damage by chronic melatonin treatment. Further investigation of these mechanisms should provide novel knowledge about pathophysiological mechanisms of cardiovascular diseases, additional explanation for their circadian and seasonal variability and potentially generate new impulses for the development of therapeutic arsenal.
- MeSH
- Antioxidants pharmacology MeSH
- Blood Vessels drug effects pathology MeSH
- Hypertension drug therapy pathology MeSH
- Cardiotonic Agents * MeSH
- Blood Pressure drug effects MeSH
- Humans MeSH
- Melatonin pharmacology MeSH
- Animals MeSH
- Check Tag
- Humans MeSH
- Animals MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Review MeSH
- Names of Substances
- Antioxidants MeSH
- Cardiotonic Agents * MeSH
- Melatonin MeSH
RNA polymerase in bacteria is a multisubunit protein complex that is essential for gene expression. We have identified a new subunit of RNA polymerase present in the high-A+T Firmicutes phylum of Gram-positive bacteria and have named it ε. Previously ε had been identified as a small protein (ω1) that copurified with RNA polymerase. We have solved the structure of ε by X-ray crystallography and show that it is not an ω subunit. Rather, ε bears remarkable similarity to the Gp2 family of phage proteins involved in the inhibition of host cell transcription following infection. Deletion of ε shows no phenotype and has no effect on the transcriptional profile of the cell. Determination of the location of ε within the assembly of RNA polymerase core by single-particle analysis suggests that it binds toward the downstream side of the DNA binding cleft. Due to the structural similarity of ε with Gp2 and the fact they bind similar regions of RNA polymerase, we hypothesize that ε may serve a role in protection from phage infection.
- MeSH
- Bacillus subtilis enzymology MeSH
- DNA-Directed RNA Polymerases chemistry genetics metabolism MeSH
- Phylogeny MeSH
- Protein Conformation MeSH
- Models, Molecular MeSH
- Molecular Sequence Data MeSH
- Protein Subunits MeSH
- Gene Expression Regulation, Enzymologic MeSH
- Gene Expression Regulation, Bacterial MeSH
- Amino Acid Sequence MeSH
- Animals MeSH
- Check Tag
- Animals MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Names of Substances
- DNA-Directed RNA Polymerases MeSH
- Protein Subunits MeSH
Tick-borne encephalitis virus (TBEV) is a member of the genus Flavivirus. It can cause serious infections in humans that may result in encephalitis/meningoencephalitis. Although several studies have described the involvement of specific genes in the host response to TBEV infection in the central nervous system (CNS), the overall network remains poorly characterized. Therefore, we investigated the response of DAOY cells (human medulloblastoma cells derived from cerebellar neurons) to TBEV (Neudoerfl strain, Western subtype) infection to characterize differentially expressed genes by transcriptome analysis. Our results revealed a wide panel of interferon-stimulated genes (ISGs) and pro-inflammatory cytokines, including type III but not type I (or II) interferons (IFNs), which are activated upon TBEV infection, as well as a number of non-coding RNAs, including long non-coding RNAs. To obtain a broader view of the pathways responsible for eliciting an antiviral state in DAOY cells we examined the effect of type I and III IFNs and found that only type I IFN pre-treatment inhibited TBEV production. The cellular response to TBEV showed only partial overlap with gene expression changes induced by IFN-β treatment - suggesting a virus-specific signature - and we identified a group of ISGs that were highly up-regulated following IFN-β treatment. Moreover, a high rate of down-regulation was observed for a wide panel of pro-inflammatory cytokines upon IFN-β treatment. These data can serve as the basis for further studies of host-TBEV interactions and the identification of ISGs and/or lncRNAs with potent antiviral effects in cases of TBEV infection in human neuronal cells.
- MeSH
- Transcriptional Activation MeSH
- Cytokines genetics immunology MeSH
- Host-Pathogen Interactions MeSH
- Interferons genetics immunology MeSH
- Encephalitis, Tick-Borne genetics immunology virology MeSH
- Humans MeSH
- Neurons immunology virology MeSH
- Encephalitis Viruses, Tick-Borne genetics physiology MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Names of Substances
- Cytokines MeSH
- Interferons MeSH
The European Union's (EU) environmental legislation establishes common measures to prevent the entry and spread of invasive non-native species and to minimize their impacts. However, species that are native to at least one member state but non-native and potentially invasive in others (NPIS) are in limbo because they are neither legally regulated at the EU level nor in most member states. We used the Communication and Information Resource Centre for Administrations, Businesses and Citizens (CIRCABC) raw data on NPIS (317 taxa) to analyze their distribution across the EU and identify which biogeographical regions are the main sources of invasions. We additionally evaluated the conservation challenge posed by NPIS that are threatened within their native ranges. We performed a pairwise analysis summarizing the number of species that are native to a given member state but non-native to another and vice versa. Although distribution patterns of NPIS varied across taxa groups, overall, southern and central EU countries were both donors and recipients of NPIS. Eastern countries were mainly a source, and western and northern countries mostly received NPIS. Around 27% of NPIS were threatened in some of their EU native ranges, which is a challenge for conservation and management because some of them have serious negative effects on European biodiversity, but hitherto remain outside the scope of the EU regulation of invasive non-native species. This highlights an unresolved paradox because efforts to manage species as invasive conflict with efforts to protect them as threatened within the same territory.
Retos en la gestión de las especies invasoras amenazadas a escala continental Resumen La legislación ambiental de la Unión Europea (UE) establece medidas comunes para prevenir la entrada y dispersión de especies invasoras no nativas y para minimizar su impacto. Sin embargo, las especies que son nativas en al menos uno de los estados miembros, pero no nativas y potencialmente invasoras (ENPI) en los demás, están en un limbo ya que no están reguladas en la UE ni en la mayoría de los estados miembros. Usamos los datos brutos del Centro de Recursos de Información y Comunicación para las Administraciones, Empresas y Ciudadanos (CIRCABC) sobre las ENPI (317 taxones) para analizar su distribución en la UE e identificar qué regiones biogeográficas funcionan como principales orígenes de las invasiones. Además, evaluamos el reto que representan las ENPI amenazadas dentro de su distribución nativa. Realizamos un análisis por pares que resumió el número de especies nativas en un estado miembro pero no nativa en otro y viceversa. Aunque los patrones de distribución de las ENPI variaron entre los grupos taxonómicos, en general fueron los países del sur y centro de la UE quienes donaron y recibieron a las ENPI. Los países del este fueron principalmente un origen de ENPI; la mayoría de los del oeste y el norte fueron receptores. Un 27% de las ENPI están amenazadas en alguna de sus distribuciones nativas en la UE, lo que representa un reto para la conservación y la gestión porque algunas de las especies tienen efectos negativos serios sobre la biodiversidad europea, pero hasta ahora permanecen fuera del alcance de la regulación de la UE para las especies invasoras no nativas. Lo anterior resalta una paradoja sin resolver ya que los esfuerzos para manejar a las especies como invasoras entran en conflicto con los esfuerzos por protegerlas como amenazadas dentro del mismo territorio.
- Keywords
- 1143/2014号条例, European biogeographical regions, Regulación 1143/2014, Regulation 1143/2014, conservation paradox, especie invasora nativa, especie invasora no nativa, invasive non-native species, native invasive species, paradoja de conservación, regiones biogeográficas europeas, 保护悖论, 原生入侵物种, 外来入侵物种, 欧洲生物地理区,
- MeSH
- Biodiversity MeSH
- Endangered Species * MeSH
- Conservation of Natural Resources MeSH
- Introduced Species * MeSH
- Animals MeSH
- Check Tag
- Animals MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Geographicals
- Europe MeSH
